Fusion Orthopedics Receives HammerTech Titanium 510K FDA Approval
Fusion Orthopedics is pleased to announce HammerTech Titanium as the newest addition to their product offering. FDA 510(k) clearance was issued November 23rd, 2018. The assigned FDA 510(k) # for HammerTech is K182684.
The new Class II titanium devices are a welcomed addition to the PEEK implants in the existing HammerTech implant family and are indicated for fixation and osteotomies of the lesser toes following corrective procedures for Hammertoe, claw toe, and mallet toe. With Petite, Extra Small, Small, Medium, and Large titanium implant sizes in strait and anatomical configurations, the system is one of the most comprehensive on the market. It is designed to be made available in gamma sterile packaging or a steam sterile tray-based system according to the individual needs of surgeons, hospitals, and outpatient surgical centers.
Surgeons are given the option of either a 10-degree anatomical configuration to match the natural declination angle of the toe, or a strait cannulated style that allows for K-wire crossover for MTP joint stabilization. The decision on which implant best suits the patient can be made up to the moment of implantation since the every HammerTech Ti style is provided ready for each case in the tray. Fusion has made significant strides developing best in class instrumentation for HammerTech delivery with both a single use and reusable options.
The success of the HammerTech system is due to aggressive distal threading and proximal barbs that are designed to create a simple, quick surgical technique that is replicable. The implant resists migration in osteopenic bone and is intended to improve fusion rates in a traditionally non-union prone procedure.
This FDA clearance highlights the accelerating growth of Fusion Orthopedics. The company anticipates significant demand for the product as they round out a complete digital implant category solution with an implant for every surgeon preference.